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Big Question Mark on Indian pharmaceutical Industry
Submitted by abhi271183 on Fri, 07/18/2008 - 13:23.
in
Indian pharmaceutical companies are known for their high quality products over the world.
We have more than 80 US FDA plants in India, largest number in any country other than the US.
Indian pharmaceutical companies have huge generic market share in US as well as in UK which generates major revenue for these companies.
Now Question mark –
We have more than 20,000 pharmaceutical companies in India but how many out of them follows GMP as revised by India’s drug regulator some three years ago.
Recently US government has levelled serious allegations against India’s largest drug maker Ranbaxy Laboratories for concerning violations of federal laws including the Federal Food, Drug, and Cosmetic Act. US FDA filled an allegation against Ranbaxy suggests use of API from unapproved sources and blending it with approved API which leads to introduction of adulterated and misbranded products in US market, allegation also involves of conspiracy, false statements and healthcare frauds
US federation laws are very harsh and stringent regarding to Food, Drug, and Cosmetic. If these allegations are proved by US agencies, it could have serious consequences for Ranbaxy and may affect Ranbaxy’s US operations in big way and may leads to penalty in Billions of USD. Currently US market accounts for 23% of company’s total operation
ET had reported on July 2 that Ranbaxy’s two plants in Dewas (Madhya Pradesh) and Batamandi (Himachal Pradesh) had come under the FDA scanner and that the FDA was investigating issues relating to document fraud, cross contamination, and validation of equipment used to manufacture the products at the facilities.
Source – Economic times
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Big question mark!
We cannot say it as a mistake or "inspectors who visit & inspect are human", because really we are moving very fast and even a small mistake may leads to loss and transfer of opportunities to other emerging and developed countries such as Brazil, Russia, China etc
Dear Abhi
You have pointed towards a big question mark faced by Indian pharma industry. Even the big major players like Ranbaxy are not excluded from such illegal and unethical matters !! According to me, it is sure that such things made by the giants are happening not due to lack of knowledge, expertise or technology. Making profit in anyway may be the reason and thats why such violation of regulations are taking place. The ultimate outcome will be the reduction in good image of the indian companies in the foreign companies and limit their growth within the circle of our country. Keep scraping such good blogs..
Thanks Praseen
Dear Praseen
Very-very conguralation for getting good marks in M.Pharm 1st year and also for getting good project in International Marketing.
Big Big Question!
Really this question is very big because People in all over world knows India only just because of its Low Price and High Quality products.
This not only effect the single company but all Indian Industry is effected by this.
The Question mark is really big
Dear Abhi, You have raised a good topic and this needs real attention from the industry people. Even I have seen it that the new setup of the industry is being turned to small towns or villages and many issues are being overlooked. But we can't claim that all regulations are being overlooked some of the issues which the regulatory people will look into are masked or taken care of but some other processes which are not under the scanner or many a times skipped are taken for granted. And as you know the inspectors who visit & inspect are human, so .. That's what some issues are looked and some overlooked. But the industry really needs to look into the matter seriously because we are moving very fast in this sector and many companies are outsourcing their work to India or Many of the Indian MNC's are getting permission to produce the products, API's here so if they don't take care it will in turn affect their future plans.